Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

NCT03794583 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: RIN-PH-305
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 31

Brief Summary

This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

Conditions

Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease

Keywords

Treprostinil; Lung Diseases; Hypertension; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent was defined as any AE occurring/worsening at any time after a participant was exposed to study drug up until 7 days after the last dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Up to 4 years

Secondary Outcomes (3)

• Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)

  Baseline, Week 6

• Change From Baseline to Week 6 in Borg Dyspnea Score

  Baseline, Week 6

• Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

  Baseline, Week 6

Study Arms (1)

Inhaled Treprostinil Solution

EXPERIMENTAL

Inhaled treprostinil solution (0.6 milligrams per milliliter \[mg/mL\], 6 mcg/breath) QID during waking hours.

Drug: Inhaled treprostinil solution

Interventions

Inhaled treprostinil solution DRUG

Inhaled treprostinil solution per dose and schedule specified in the arm

Inhaled Treprostinil Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant voluntarily gives informed consent to participate in the study.
• Participant completed Study RIN-PH-304.
• Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, \[less than 1% per year\], such as approved hormonal contraceptives, barrier methods \[such as condom or diaphragm\] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
• Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.

You may not qualify if:

• The participant is pregnant or lactating.
• The participant was prematurely discontinued from Study RIN-PH-304.
• The participant is intolerant to inhaled prostanoid therapy.
• The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
• The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
• Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.

Sponsors & Collaborators

• United Therapeutics: lead
• Lung Biotechnology PBC: collaborator

Study Sites (31)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

St. Francis Sleep Allergy & Lung Institute

Clearwater, Florida, 33765, United States

Location

St. Vincent's Lung, Sleep, and Criticial Care Specialists

Jacksonville, Florida, 32204, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Pulmonary & Critical Care of Atlanta

Atlanta, Georgia, 30342, United States

Location

Georgia Clinical Research

Austell, Georgia, 30106, United States

Location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, 46260, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49546, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Carl and Edyth Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Lady Davis Carmel Medical Centre

Haifa, 34362, Israel

Location

Hadassah-Hebrew University Hospital

Jerusalem, 9112001, Israel

Location

Rabin Medical Center

Petah Tiva, 49100, Israel

Location

"Azienda Unita Sanitaria Locale Della Romagna Ospedale ""Gian Battista Morgagni"" - Luigi Pierantoni"" di Forli"

Forlì, Forli, 47121, Italy

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Hypertension; Vascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Per sponsor decision, the study was terminated early.

Results Point of Contact

• Title: United Therapeutics Global Medical Information
• Organization: United Therapeutics

305PerfectOLEStudy@lungbiotechnology.com

1-240-821-1881

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 7, 2019
• Study Start: December 21, 2018
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: December 11, 2025
• Results First Posted: December 18, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); US (27); IT (1)